Job Title: C&Q Specialist - Remediation and Expansion
We are seeking a highly skilled Commissioning and Qualification (C&Q) Specialist to lead two major initiatives at a Small Molecule site. The ideal candidate will have extensive experience in C&Q, risk-based methodologies, and GMP regulations.
About the Role:
* Lead qualification and commissioning efforts for remediation and expansion projects
* Develop C&Q strategy and plans aligned with GMP principles
* Ensure timely execution of documentation, FATs, commissioning, and qualification activities (IQ/OQ/PQ)
* Collaborate with internal stakeholders to ensure project alignment
Requirements:
* BSc/MSc degree in Life Sciences, Engineering, or related field
* Minimum 10 years of experience in Commissioning & Qualification within life sciences
* Solid knowledge of Small Molecule manufacturing and Risk-Based C&Q methodology
* Familiarity with GMP, FDA, EMA regulations
* Fluent in English; Dutch is a plus
What We Offer:
* A challenging role with opportunities for growth and development
* A collaborative work environment with experienced professionals
* The chance to make a meaningful contribution to our organization's success